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Recruitment not reached
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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.
Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol, Daily treatment, CKD | Experimental | Experimental Arm |
|
| Daily treatment for CKD | Other | Comparator Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental arm | Drug | Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albuminuria in proteinuric Chronical Kidney Disease patients | Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline albuminuria at 6 months | Determinate % of patients with an over 20% of albuminuria descent from baseline | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesús Egido de los Ríos, MD | Fundación Renal Iñigo Alvarez De Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario General de Alicante | Alicante | Alicante | 03010 | Spain | ||
| Hospital Son Espases |
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| Comparator Arm | Other | Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc. |
|
|
| Mallorca |
| Balearic Islands |
| 07010 |
| Spain |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08035 | Spain |
| Fundació Puigvert | Barcelona | Barcelona | 08025 | Spain |
| Hospital Valle de Hebrón | Barcelona | Barcelona | 08035 | Spain |
| Hospital de Galdakao | Bilbao | Basque Country | 48960 | Spain |
| Hospital Virgen de la Candelaria | Santa Cruz de Tenerife | Canary Islands | 38010 | Spain |
| Hospital Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Hospital Comarcal Da Costa | Burela de Cabo | Lugo | 27880 | Spain |
| Hosp. U. Fundación de Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal | Madrid | Madrid | 28034 | Spain |
| Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Fundación Jiménez Díaz | Madrid | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Infanta Sofía | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Hospital Carlos Haya | Málaga | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital Dr Peset | Valencia | Valencia | 46017 | Spain |
| Hospital Clinico Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D004194 | Disease |
| D011507 | Proteinuria |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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